Improving pediatric multiple sclerosis interventional phase III study design: a meta-analysis.

ABSTRACT:

Background

To support innovative trial designs in a regulatory setting for pediatric-onset multiple sclerosis (MS), the study aimed to perform a systematic literature review and meta-analysis of relapse rates with interferon β (IFN β), fingolimod, and natalizumab and thereby demonstrate potential benefits of Bayesian and non-inferiority designs in this population.

Methods

We conducted a literature search in MEDLINE and EMBASE from inception until 17 June 2020 of all studies reporting annualized relapse rates (ARR) in IFN β-, fingolimod-, or natalizumab-treated patients with pediatric-onset relapsing-remitting MS. These interventions were chosen because the literature was mainly available for these treatments, and they are currently used for the treatment of pediatric MS. Two

SUBMITTER: Graves JS 

PROVIDER: S-EPMC9066624 | biostudies-literature | 2022

REPOSITORIES: biostudies-literature